Occurrence of Pregnancy Sample Clauses

Occurrence of Pregnancy. Any female subject who becomes pregnant while participating in this study will be followed to determine the outcome of the pregnancy. Generally, follow-up will be no longer than 6 to 8 weeks following the estimated delivery date. The investigator, or his or her designee, will collect pregnancy information on the appropriate GW form and submit it to GW within 2 weeks of learning of the subject’s pregnancy. While pregnancy itself is not considered to be an adverse event (AE) or SAE, any pregnancy complication or elective termination of a pregnancy for medical reasons will be recorded as an AE or a SAE, as described in Section 7.6, “Documenting AEs and SAEs” and will be followed-up as described in Section 7.7, “Follow-up of AEs and SAEs”. Furthermore, any SAE occurring as a result of a post-study pregnancy and is reasonably related to the study drug will be reported to GW as described in Section 7.10, “Post-study AEs and SAEs,” if the investigator learns of this SAE through spontaneous reporting. In addition, the investigator, or his or her designee, will notify GW and collect pregnancy information on a male study subject’s female partner who becomes pregnant during the male subject’s participation in the study, if the investigator learns of this pregnancy through spontaneous reporting. Female subjects who become pregnant during the course of the study must be withdrawn.